Revised transparency rules for the EU Clinical Trials Information System (CTIS)
EMA has adopted revised transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System. The simplifications introduced will give access to clinical trial information to stakeholders including patients and healthcare professionals in a faster and more efficient way.
One of the key changes of the revised rules is the removal of the deferral mechanism, which allowed sponsors to delay the publication of certain data and documents for up to seven years after the end of the trial to protect personal data and commercially confidential information (CCI).
The updated rules strike a balance between transparency of information and protection of commercially confidential information. They benefit patients, because key clinical trial information, that patients flagged as being most relevant for them, is published early. They also introduce process simplifications that benefit clinical trial sponsors who have to protect commercially confidential information and personal data. Finally, they benefit healthcare professionals because the resulting system is more user-friendly, facilitating access to information about clinical trials and enrolment in clinical trials, and also increasing awareness of possible treatment options.
The updates were triggered by feedback from stakeholders and experience after the launch of the system. An eight-week public consultation was held between May and June 2023.
The revised transparency rules will apply after their technical implementation in CTIS, including its public portal, which is expected to be finalised in the second quarter of 2024. The effective date of completion of the process and the entry into application of the new rules will be communicated to the users of the system before they become applicable.
CTIS is the single-entry point in the EU for the submission and assessment of applications for clinical trials for sponsors and regulators. The system includes a public searchable database for healthcare professionals, patients and the general public to deliver the high level of transparency foreseen by the regulation.
The authorisation and oversight of clinical trials is the responsibility of EU / EEA Member States while EMA is responsible for maintaining the CTIS. The European Commission oversees the implementation of the Clinical Trials Regulation.